MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS HEART VALVE; TISSUE HEART VALVE

Model Number PVF-S

Device Problem Difficult to Open or Close (2921)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/17/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval plus valve size s (pvf-s) was implanted as part of an aortic valve replacement procedure.After the implant, the tee showed severe perivalvular leak (pvl).The correct position of the perceval plus valve was confirmed with the post implant tee.The perceval valve was consequently explanted intraoperatively.The annulus was re-examined for any possible leftover calcium deposits and was re-sized.A new perceval plus valve pvf-s was ultimately implanted.The tee confirmed a good functionality of the new valve implanted.Upon visual inspection of the affected valve, a structural problem was identified.The patient¿s postoperative course was complicated by mitral valve regurgitation, that was not directly linked with the perceval valve implantation.On (b)(6) 2021, a perceval plus valve size s (pvf-s) was implanted as part of an aortic valve replacement procedure.After the implant, the tee showed severe perivalvular leak (pvl).The correct position of the perceval plus valve was confirmed with the post implant tee.The perceval valve was consequently explanted intraoperatively.The annulus was re-examined for any possible leftover calcium deposits and was re-sized.A new perceval plus valve pvf-s was ultimately implanted.The tee confirmed a good functionality of the new valve implanted.Upon visual inspection of the affected valve, a structural problem was identified.The patient¿s postoperative course was complicated by mitral valve regurgitation, that was not directly linked with the perceval valve implantation.

• Brand Name: PERCEVAL PLUS SUTURELESS HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 12181327
• MDR Text Key: 262028751
• Report Number: 1718850-2021-01128
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/22/2022
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2021
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention